Clinical Trial

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Recruiting
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Summary
The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-30
notable Primary completion pushed: 2026-04 -> 2027-09 2026-05-30
minor Completion pushed: 2027-04 -> 2027-09 2026-05-30
Trial Details
NCT Number NCT07235592
Lead Sponsor Santen SAS
Conditions Primary Open Angle Glaucoma
Enrollment 112 participants
Start Date 2026-03-19
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-16